With only a few minutes left of a company's internal quarterly conference, word began to circulate by email and whispers that the FDA had cleared a new blood meter-insulin pump device for sale in the United States.
An email bounced between the regulatory arm of Roche Diagnostics' diabetes division to one of the company's corporate communications chiefs, setting a chain of events in motion just about 12pm on Wednesday, July 18.
The Accu-Chek Combo has been available abroad since 2008, including places like France, Germany, the UK and also Australia, but it's been awaiting regulatory approval here in the U.S. for more than a year, despite the fact that Roche received its 510(k) premarket notification number back in May 2011.
That's nothing out of the ordinary — the FDA process takes time. (Some think too much time, but that's another discussion...)
Put simply, this newly-approved device is a competitor to the Animas Ping in how it uses Bluetooth technology to connect a meter and pump. Yes, the meter and pump can "talk to each other" both ways, sending not only blood sugar results back and forth but also bolus and pump commands. The glucose meter serves as a remote control, allowing the user to control pump features, like boluses, basal rates and temp basals.
This particular pump has a 315-unit reservoir for insulin (!) — something I personally appreciate, since you never seem to get the actual full amount of insulin the reservoir holds after priming the tubing and infusion set on most pumps.
But product "Oohs" and "Aahs" aside, the behind-the-scenes story of how the news of FDA approval materialized is an interesting one that illustrates what diabetes company officials typically go through. The long wait is a necessary part of any product's FDA approval, and of course the finding out... We all see the news releases announcing these things, including the typical "canned" quotes from the highest company officials, saying how proud they are and what a difference their new product will make for us consumers. Yada, yada, yada...
This isn't the first FDA clearance Roche has received this year for an Accu-Chek product. In January, the federal agency cleared the Accu-Chek Nano SmartView blood meter system that's smaller than a credit card and a version of the Nano was already available overseas. The Nano is now available to buy here in the U.S., as another Roche-released news alert informed us earlier this week.
But this Accu-Chek Combo clearance is the first FDA green light for one of Roche's pump-specific products in six years!
We wanted a peek behind the scenes, at the human reactions of the people who've spent so much of their time fine-tuning the product and ushering it through the FDA process, and Roche Diabetes Care's communications manager Todd Siesky was happy to oblige.
These individuals are working for us, basically, so it's important to recognize their work and feedback — reading between the news release lines, as it were.
Siesky says Roche had been having "productive" live discussions with the FDA about the product for some time, so they had a general idea that they'd hear from the agency sometime this summer about the Combo. But no one thought the OK would come during their quarterly town hall-style meeting last week, held at the Roche Diagnostics headquarters on the north side of Indianapolis, where a couple hundred company officials (!) were convened in an all-morning conference focused on finances, sales and strategy.
Siesky had long been mapping out a communications plan for the eventual FDA decision on the Combo, setting up a "grid" to get the news out as soon as possible using a variety of channels depending on what the FDA might say. Significant thought went into whether the global company's headquarters in Switzerland and Diabetes Care headquarters in Germany would want to send out their own press releases, and whether timing of that might coincide with factors such as the stock market opening times.
Siesky says last week, he was the one who saw the approval email first, and took a note to the podium at the front of the room where Marc Gibeley, head of Roche Diabetes Care North America, was addressing the crowd and about to turn to the ending Q&A.
The room erupted into cheers and applause and people were hugging each other, as they heard that the company's hard work had finally paid off, according to the insulin delivery systems marketing director Nancy Dean.
"I got chills as soon as I heard it, and I still get chills thinking about that moment," she says.
Immediately, a cascade of news-announcing and congratulatory emails shot out throughout the company — to those who weren't there and hadn't heard about the approval yet.
"Everyone just had a collective sigh of relief and were glad we could focus on getting this product out to people here in the U.S.," Dean said.
Once the officials absorbed the initial news, the gears began turning on the marketing and production of this new product. Their next move is to begin manufacturing the Combo for the U.S. launch and finalizing the company processes and systems to begin accepting and shipping customer orders, Siesky says.
"We could have all the marketing and training programs set up ahead of time, but until it's cleared by the FDA nothing can go into effect. We have to wait to put everything into practice. Projects may have sat for awhile that we can get started up again, so there's a lot to do before we get this out on the market."
For example, the company is able to start talking about the product in a limited degree at trade booths once they file with the FDA, but post-approval, the marketing can change to product details, and they have to make sure all the FDA-cleared information matches the previously-vetted product information that the original marketing was built on.
Then there's the product intro and training that starts for the sales force, to ensure that everyone is getting the right education for what was actually approved.
In total, everything takes generally about two or three months from the FDA approval to get ready to go to market, Siesky said.
"There's excitement more than anything, because this is something we've been working on for a while and now it's finally coming to fruition," Siesky said.
The Combo is expected to hit market this year (in 2012), Roche officials say. Exact timing isn't known, but their corporate PR says in "the second half of 2012" (um, it is nearly August). Some online information also points to October.
What's So Special About the Accu-Chek Combo?
Dean describes it as a device that PWDs can use to keep their diabetes "out of sight, but in control." Like the Animas Ping, it's particularly nice for those who don't like wear their pumps on their belts; everything can be run off the "smart meter" with no need to pull out your pump. It has a basal "advice" calculator. The meter has an e-diary for logging BGs, and a color screen.
Honestly, I don't see what the fuss is all about. Seriously, this is not a novel idea. My Medtronic has been communicating with my meter for years, and my pump can be wireless uploaded to an online program for data review. Maybe it's not "Bluetooth two-way communication" but rather an RF signal, but still... it does what I need it to. And I always wear it on my belt for easy access, so I'm not all too impressed with the "discreet" message here.
Dean points out that this two-way Bluetooth communication between devices is a "key stepping stone" in the company's plan to bring PWDs more integrated diabetes management devices, as all the D-device companies are striving to do these days. That's all good, but we do believe there's still much more to be desired... For me personally, I like the idea of this new "smart meter integration" by Roche, but it's not quite "wow" enough to motivate me to change pumps from the Medtronic Paradigm system I'm currently using, which is actually integrated with a CGM!
What About the Patch Pump?
Meanwhile, Roche has yet to launch the OmniPod competitor Solo patch pump that the company acquired more than two years ago (!). New diabetes tech just moves very slowly through the pipeline, apparently.
So much so that Accu-Chek marketing director Dean says the FDA-approved 1.0 version of the Solo pump won't be commercially marketed in the U.S. at all, and the second generation they are working on hasn't even been submitted for FDA approval yet (what?!).
There's also no word at this point on the timing of when future Accu-Chek Spirit pumps will be integrated with the Dexcom CGM — frustrating! But the Combo approval is best seen as a step in the right direction.
Roche Social Media Summit
We're looking forward to reporting more details on the Combo system and the larger diabetes device picture from the upcoming Roche Diabetes Social Media Summit next week (happening just prior to the 2012 Annual Meeting of the American Association of Diabetes Educators, which we're also attending). About 31 diabetes advocates will be converging in Indy, including some new faces.
A preview provided by Roche earlier this week mentions these topics: the Diabetes Online Community's evolution (as we've written about recently), technology and innovation, a product portfolio update, and a "crowdsourcing Q&A" on social media use in the diabetes and healthcare worlds. There will also be a tour of the facilities where some Roche meters, strips and diabetes devices are made. Always fascinating to see!
You can follow the hashtag #dsummit12 for event coverage.
We at the 'Mine have always been conscious about asking readers what they'd love to learn from these events, and it's great to see communities like TuDiabetes and Diabetes Daily picking up this thread.
We're excited to have a chance to not only get an inside peek at this company's U.S. headquarters (!), but also to report further on what's happening "behind the press releases." Stay tuned for updates from Indianapolis.